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Abstract：
Mesenchymal stromal cell (MSC) transplantation can improve the left ventricular ejection fraction (LVEF) after an acute myocardial infarction (AMI). Transplanted MSCs exert a paracrine effect, which might be augmented if repeated doses are administered. This study aimed to compare the effects of single versus double transplantation of Wharton\'s jelly MSCs (WJ-MSCs) on LVEF post-AMI.
We conducted a single-blind, randomized, multicenter trial. After 3-7 days of an AMI treated successfully by primary PCI, 70 patients younger than 65 with LVEF < 40% on baseline echocardiography were randomized to receive conventional care, a single intracoronary infusion of WJ-MSCs, or a repeated infusion 10 days later. The primary endpoint was the 6-month LVEF improvement as per cardiac magnetic resonance (CMR) imaging.
The mean baseline EF measured by CMR was similar (~ 40%) in all three groups. By the end of the trial, while all patients experienced a rise in EF, the most significant change was seen in the repeated intervention group. Compared to the control group (n = 25), single MSC transplantation (n = 20) improved the EF by 4.54 ± 2%, and repeated intervention (n = 20) did so by 7.45 ± 2% when measured by CMR imaging (P < 0.001); when evaluated by echocardiography, these values were 6.71 ± 2.4 and 10.71 ± 2.5%, respectively (P < 0.001).
Intracoronary transplantation of WJ-MSCs 3-7 days after AMI in selected patients significantly improves LVEF, with the infusion of a booster dose 10 days later augmenting this effect.
Trial registration: Iranian Registry of Clinical Trials, IRCT20201116049408N1. Retrospectively Registered 20 Nov. 2020, https://en.irct.ir/trial/52357.
We conducted a single-blind, randomized, multicenter trial. After 3-7 days of an AMI treated successfully by primary PCI, 70 patients younger than 65 with LVEF < 40% on baseline echocardiography were randomized to receive conventional care, a single intracoronary infusion of WJ-MSCs, or a repeated infusion 10 days later. The primary endpoint was the 6-month LVEF improvement as per cardiac magnetic resonance (CMR) imaging.
The mean baseline EF measured by CMR was similar (~ 40%) in all three groups. By the end of the trial, while all patients experienced a rise in EF, the most significant change was seen in the repeated intervention group. Compared to the control group (n = 25), single MSC transplantation (n = 20) improved the EF by 4.54 ± 2%, and repeated intervention (n = 20) did so by 7.45 ± 2% when measured by CMR imaging (P < 0.001); when evaluated by echocardiography, these values were 6.71 ± 2.4 and 10.71 ± 2.5%, respectively (P < 0.001).
Intracoronary transplantation of WJ-MSCs 3-7 days after AMI in selected patients significantly improves LVEF, with the infusion of a booster dose 10 days later augmenting this effect.
Trial registration: Iranian Registry of Clinical Trials, IRCT20201116049408N1. Retrospectively Registered 20 Nov. 2020, https://en.irct.ir/trial/52357.
摘要：
背景：间充质基质细胞（MSC）移植可以改善急性心肌梗死（AMI）后的左心室射血分数（LVEF）。移植的MSCs发挥旁分泌作用，如果重复给药，可能会增加。本研究旨在比较沃顿胶质细胞间充质干细胞(WJ-MSCs)单次和两次移植对AMI后LVEF的影响。
方法：我们进行了单盲，随机化，多中心试验。在通过直接PCI成功治疗AMI3-7天后，70例基线超声心动图LVEF<40％的年龄小于65岁的患者被随机分配接受常规治疗。一次冠状动脉内输注WJ-MSCs，或10天后重复输液。主要终点是根据心脏磁共振（CMR）成像的6个月LVEF改善。
结果：在所有三组中，通过CMR测量的平均基线EF相似（〜40％）。审判结束时,虽然所有患者都经历了EF上升，最显著的变化见于重复干预组.与对照组(n=25)相比，单个MSC移植（n=20）使EF提高了4.54±2％，通过CMR成像测量时，重复干预（n=20）增加了7.45±2％（P<0.001）；通过超声心动图评估时，这些值分别为6.71±2.4和10.71±2.5%，分别(P<0.001)。
结论：部分患者在AMI后3-7天冠状动脉内移植WJ-MSCs可显著改善LVEF，10天后输注加强剂量可增强这种效果。
背景：试验注册：伊朗临床试验注册，IRCT20201116049408N1。11月20日回顾性注册2020，https://en。irct.ir/trial/52357。
方法：我们进行了单盲，随机化，多中心试验。在通过直接PCI成功治疗AMI3-7天后，70例基线超声心动图LVEF<40％的年龄小于65岁的患者被随机分配接受常规治疗。一次冠状动脉内输注WJ-MSCs，或10天后重复输液。主要终点是根据心脏磁共振（CMR）成像的6个月LVEF改善。
结果：在所有三组中，通过CMR测量的平均基线EF相似（〜40％）。审判结束时,虽然所有患者都经历了EF上升，最显著的变化见于重复干预组.与对照组(n=25)相比，单个MSC移植（n=20）使EF提高了4.54±2％，通过CMR成像测量时，重复干预（n=20）增加了7.45±2％（P<0.001）；通过超声心动图评估时，这些值分别为6.71±2.4和10.71±2.5%，分别(P<0.001)。
结论：部分患者在AMI后3-7天冠状动脉内移植WJ-MSCs可显著改善LVEF，10天后输注加强剂量可增强这种效果。
背景：试验注册：伊朗临床试验注册，IRCT20201116049408N1。11月20日回顾性注册2020，https://en。irct.ir/trial/52357。
